Flex Team Member in Lab Support and Compliance
vor 7 Monaten
**Beschreibung**:
Wir suchen für unseren Kunden, F. Hofmann-La Roche Ltd. mit Sitz in Basel, per sofort einen motivierten und engaigerten **Flex Team Member in Lab Support and Compliance / Sample Coordination** für einen befristeten Einsatz von einem Jahr mit Option auf Verlängerung.
Die Sektion Lab Support and Compliance gehört zum Bereich ”Operations Support & Compliance” (OSC) innerhalb der “Synthetic Molecules Technical Development” (PTDC) am Standort Basel. Der Bereich ist zuständig für “late stage” technische Entwicklung unserer Synthetic Molecules Pipeline von Drug Substances (DS) und Drug Products (DP) für klinische Studien.
Die Sektion gewährleistet Schlüssel-Support Aktivitäten für interne Partner wie PTDE, zuständig für die Entwicklung von Large Moleküle Produkten, davon z.B. parenterale. In diesem Zusammenhang ist die Sektion verantwortlich für die reibungslose Musterkoordination zwischen dem Logistikbereich und den verschiedenen Partnern (Stability Management, diverse analytische Labore, Produktion, CSC, etc).
**Tätigkeiten**:
- Hauptaufgaben befinden sich im Bereich Musterkoordination für PTDE
- Musterannahme
- Mustervorbereitung (Sortieren, Etikettieren)
- Mustertransport
- Unterstützung bei der Einlagerung von Stabilitätsmustern
- Einweisungen im LIMS System
- Review und Sicherstellung einer aktuellen GMP-Dokumentation
- Mitarbeit/Erstellung aufgabenbezogener Dokumente (z.B. SOPs) und verantwortlich für deren Einhaltung
- Vorschlag/Implementierung Prozessverbesserungen und Harmonisierungen
- Vertretung und Support der anderen Flex-Team-Mitglieder der Sektion
- Unterstützung bei Inspektionen und Audits, die den betreuten Bereich betreffen
- Unterstützung/Mitarbeit in aufgabenbezogenen und relevanten Projekten (kontinuierliche Verbesserung, IT und CSV etc)
- Kritische Bewertung der eigenen Arbeitsergebnisse
**Anforderungen**:
- Berufsausbildung Logistik, Labor, Produktion oder vergleichbares mit relevanter Berufserfahrung
- Mindestens 2 Jahre Berufserfahrung im GMP-Umfeld und mit SOPs
- Gute EDV Kenntnisse und Vertrautheit im Umgang mit Datenbanken, LIMS Kenntnisse von Vorteil
- Sehr gute Deutschkenntnisse in Wort und Schrift sowie gute Englischkenntnisse
- Sehr hohe Teamfähigkeit und Kommunikationsfähigkeit
- Hohes Qualitäts
- und Sicherheitsbewusstsein
- Sehr hohe Kundenorientierung, Aufbau und Pflege der Beziehung mit den internen und externen Partnern
- Sehr hohe Flexibilität sowie Organisationstalent, hohe Einsatzbereitschaft, Zuverlässigkeit und Selbständigkeit
- Leidenschaft für kontinuierliche Verbesserungsaktivitäten (Vorschlagskraft erwartet)
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